{
  "code": "JOJ",
  "deviceName": "Indicator, Physical/Chemical Sterilization Process",
  "deviceClass": "II",
  "regulationNumber": "880.2800",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 264,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 80,
    "last12Months": 14
  },
  "reviewDays": {
    "median": 113,
    "sampleSize": 264
  },
  "recalls": {
    "total": 24,
    "recent": [
      {
        "resNumber": "Z-0836-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "TERRAGENE S.A.",
        "firmAsPublished": "TERRAGENE S.A.",
        "reason": "Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.",
        "initiated": "2023-12-07"
      },
      {
        "resNumber": "Z-1609-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "3M Company - Health Care Business",
        "firmAsPublished": "3M Company - Health Care Business",
        "reason": "3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.",
        "initiated": "2023-04-06"
      },
      {
        "resNumber": "Z-1610-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "3M Company - Health Care Business",
        "firmAsPublished": "3M Company - Health Care Business",
        "reason": "3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.",
        "initiated": "2023-04-06"
      },
      {
        "resNumber": "Z-1736-2022",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Steris Corporation Hopkins Facility",
        "firmAsPublished": "Steris Corporation Hopkins Facility",
        "reason": "Product contains incorrect chemical indicators in packaging.",
        "initiated": "2022-08-10"
      },
      {
        "resNumber": "Z-1792-2022",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.",
        "initiated": "2022-05-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260181",
      "deviceName": "LF Process Indicator Tape for Steam Sterilization",
      "applicant": "Intertape Polymer Group",
      "company": "Intertape Polymer Group",
      "decisionDate": "2026-02-20",
      "dateReceived": "2026-01-21"
    },
    {
      "kNumber": "K251991",
      "deviceName": "SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)",
      "applicant": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.",
      "company": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.",
      "decisionDate": "2025-12-23",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K251035",
      "deviceName": "DISINTEK™ PA Test Strips",
      "applicant": "Serim Research",
      "company": "Serim Research Corporation",
      "decisionDate": "2025-06-03",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K251048",
      "deviceName": "Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118",
      "applicant": "STERIS Corporation",
      "company": "Steris Corporation",
      "decisionDate": "2025-05-02",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K243876",
      "deviceName": "VERIFY STEAM Integrating Indicator",
      "applicant": "STERIS Corporation",
      "company": "Steris Corporation",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-12-18"
    },
    {
      "kNumber": "K250172",
      "deviceName": "Green Card Bowie-Dick Test (BD115)",
      "applicant": "Steritec Products, Inc. (A Getinge Company)",
      "company": "Steritec Products, Inc. (A Getinge Company)",
      "decisionDate": "2025-02-20",
      "dateReceived": "2025-01-21"
    },
    {
      "kNumber": "K242860",
      "deviceName": "Type 5 Integrating Indicator for Steam (CSPN-15)",
      "applicant": "True Indicating, LLC",
      "company": "True Indicating, LLC",
      "decisionDate": "2025-01-17",
      "dateReceived": "2024-09-20"
    },
    {
      "kNumber": "K241036",
      "deviceName": "Autoclave Indicator Tape; EO Indicator Tape",
      "applicant": "Jiangmen New Era External Use Drug Co., Ltd.",
      "company": "Jiangmen New Era External Use Drug Co., Ltd.",
      "decisionDate": "2024-12-17",
      "dateReceived": "2024-04-16"
    },
    {
      "kNumber": "K243475",
      "deviceName": "Chemical Indicator for enspire CLCSPS (LCC015)",
      "applicant": "STERIS Corporation",
      "company": "Steris Corporation",
      "decisionDate": "2024-12-04",
      "dateReceived": "2024-11-08"
    },
    {
      "kNumber": "K242795",
      "deviceName": "Getinge Assured MI Steam Migrating Integrator",
      "applicant": "Steritec Products Mfg. (A Getinge Group Company)",
      "company": "Steritec Products Mfg. (A Getinge Group Company)",
      "decisionDate": "2024-10-15",
      "dateReceived": "2024-09-16"
    }
  ],
  "topApplicants": [
    {
      "name": "STERIS Corporation",
      "count": 36
    },
    {
      "name": "3M Company",
      "count": 24
    },
    {
      "name": "Spsmedical Supply Corp.",
      "count": 17
    },
    {
      "name": "Albert Browne , Ltd.",
      "count": 16
    },
    {
      "name": "Steritec Products Mfg Co, Inc.",
      "count": 16
    }
  ],
  "topCompanies": [
    {
      "name": "Steris Corporation",
      "count": 42,
      "spellings": 2
    },
    {
      "name": "3M Company",
      "count": 24,
      "spellings": 1
    },
    {
      "name": "Spsmedical Supply Corp. A Division of Cantel Medical",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Albert Browne , Ltd.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "STERITEC PRODUCTS MFG. CO., INC.",
      "count": 16,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Intertape Polymer Group",
      "since": "2026-02-20",
      "kNumber": "K260181"
    },
    {
      "name": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.",
      "since": "2025-12-23",
      "kNumber": "K251991"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JOJ (Indicator, Physical/Chemical Sterilization Process) has two findings, most consequential first. 2 first-time filers in the last 12 months, Intertape Polymer Group and Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd (K260181, K251991). The code is crowded, scoring 68 of 100 — 75 companies hold a clearance here and 2 arrived in the last 12 months (JOJ:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Intertape Polymer Group and Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.",
        "recordIds": [
          "K260181",
          "K251991"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 68 of 100 — 75 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "JOJ:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AJOJ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJOJ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJOJ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJOJ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJOJ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJOJ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJOJ"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.724Z"
}